Events

Retiro De Equipo (Recall) de Device Recall StoneBreaker Exhaust Line

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cook Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79731
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1592-2018
  • Fecha de inicio del evento
    2018-01-31
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163192
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lithotriptor, electro-hydraulic - Product Code FFK
  • Causa
    The interior of the product may not be sterilized to the appropriate sterility assurance level when following the reprocessing instructions in the instructions for use.
  • Acción
    On March 8, 2018 Cook Medical sent customers notification of an Urgent Medical Device Recall . Customers were instructed to complete the following actions: 1. Examine inventory immediately to determine if you have affected product, and quarantine affected product(s). Immediately cease all distribution and use of these products. 2.Return affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form. Used devices being returned should be double-bagged, placed inside an outer puncture free package with sufficient cushioning material to prevent movement between the secondary container and the outer package. An itemized list of the components must be placed in the container and the outer package marked Used Medical Device. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. Immediately report adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Customers with medical questions or concerns can contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

Device

Device Recall StoneBreaker Exhaust Line
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA
  • Descripción del producto
    StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA